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A study to explore the efficacy of PTR-36 in adult patients with asthma

A randomized, double-blind, placebo-controlled, parallel group study to explore the efficacy of PTR-36 in adult patients with bronchial asthma (Phase 2)

Status
Unknown
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2080222805
Enrollment
150
Registered
2015-03-25
Start date
2015-03-25
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

asthma

Interventions

investigational material(s) Generic name etc : PTR-36 INN of investigational material : Therapeutic category code : 229 Other agents affecting respiratory organs Dosage and Administration for Investi

Sponsors

TEIJIN PHARMA LIMITED
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: - Asthma patients receiving a moderate-dose ICS or a moderate-dose ICS/long-acting beta2-agonist(LABA)combination therapy for more than 4 weeks - FEV1 >=60% and =<90% of the predicted normal value at randomization

Exclusion criteria

Exclusion criteria: - BMI >= 30 - smoking history > 10 pack year - diagnosed with COPD

Design outcomes

Primary

MeasureTime frame
Changes in mPEF from time of randomization to final evaluation

Secondary

MeasureTime frame
Changes in pre-bronchodilator FEV1, ACQ7, and FeNO

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026